Voluntary National Retail Food Regulatory Program Standards

Forms and Documents

Document Name	Status
Form 3958 Submission of Form FDA 3958 Form and Instruction	Modified
0621 ss 7-26-2017.docx Supporting Statement A	2017-07-26

IC Document Collections

IC ID	Document Title	Status
197119	Reporting: Requests for Documentation of Successful Completion of Staff Training Other-Program Standards	Modified
197118	Reporting - Voluntary National Retail Food Regulatory S tandards - Form FDA 3520 Other-Program Standard	Removed
183429	Submission of Form FDA 3958 Form and Instruction	Modified
183428	FDA Worksheets: compile information, review instructions, create records Other-Program Standards	Modified

ICR Details

OMB Control No: 0910-0621	ICR Reference No: 201706-0910-011
Status: Historical Active	Previous ICR Reference No: 201405-0910-023
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Voluntary National Retail Food Regulatory Program Standards
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/28/2017
	Date Received in OIRA: 07/26/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2020	36 Months From Approved	08/31/2017
Responses	2,500	0	3,000
Time Burden (Hours)	47,345	0	47,395
Cost Burden (Dollars)	0	0	0

---

Abstract: This request seeks information from federal, state, local, territorial, and tribal entitities regarding the establishment of regulatory program standards to ensure the safety of retail food service establishments. Respondents use the national standards developed by FDA to address risk factors associated with food retail service and to assess the effectiveness of the programs implemented to safeguard against foodborne illness. Adherence to the program allows respondents to seek listing in FDA's National Registry Report.

---

Authorizing Statute(s): US Code: 21 USC 393(b)(4) Name of Law: FFDCA
   US Code: 42 USC 243 Name of Law: PHS Act
   US Code: 21 USC 393(b)(2)(A) Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 14369	03/20/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 32839	07/18/2017
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
FDA Worksheets: compile information, review instructions, create records
Submission of Form FDA 3958	3958	FDA National Registry Report
Reporting: Requests for Documentation of Successful Completion of Staff Training
Reporting - Voluntary National Retail Food Regulatory S tandards - Form FDA 3520	3520	Permission to Publish in National registry

---

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	2,500	3,000	0	0	-500	0
Annual Time Burden (Hours)	47,345	47,395	0	0	-50	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The information collection reflects adjustments. As previously discussed, we estimate the consolidation of Forms FDA 3519 and 3520 into new Form 3958 has resulted in a reduction of 50 burden hours with a corresponding reduction in annual responses of 500.

---

Annual Cost to Federal Government: $23,618

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

---

Common Form ICR:  No

---

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 07/26/2017

---